Adjustable miniature panoramic illumination and infusion system for retinal surgery

ABSTRACT

A medical device for eye surgery, particularly retinal surgery, combines a flow of infusing fluid and optical fiber illumination. The device uses a single strand of plastic optical fiber which extends through bores in a juncture device, tube and needle cannula with sufficient clearance to permit the flow of the infusing fluid.

FIELD OF THE INVENTION

The present invention relates to medical devices and more particularly acombined source of illumination and fluid infusion for eye surgery,especially opthalmic retinal surgery.

BACKGROUND OF THE INVENTION

At the present time a number of different lighting sources are utilizedfor eye surgical operations. However, some of these light sources arenot suitable for retinal operations as they do not provide sufficientlight to the back of the eyeball. In addition, some of the light sourcesrequire the eye surgeon to physically hold a light probe, which uses oneof his hands and leaves only one hand free for manipulating surgicalinstruments.

One type of surgical technique involves the use of a suitable fluid,such as saline solution, silicon oil or a gas, which is injected intothe eyeball during a surgical procedure to maintain the eyeball in aninflated state. This technique is called "infusion" and requires asource of fluid, a tube (infusion cannula) leading from the source and aneedle cannula connected to the tube and used to inject the fluid intothe eyeball. The needle must generally be retained in place during theoperation so that the fluid may be constantly replenished.

Often, in the case of retinal surgery (vitrectomy surgery) it is desiredthat the light source be within the eyeball (within the globe) in theform of an internal light (endoillumination). This permits the directlight of the operating microscope to be turned off and reduces glare atthe cornea and corneal contact lens surfaces.

A presently commercially available system for vitro-retinal surgerycombining illumination and infusion is the "DPS 100" (TM), from StorzInstrument GmbH, Im Schuhmachergewann 4, D-6900 Heidelberg 1, Germany("Storz system"). In the Storz system three incisions are made in theeye, each 2.8 mm in length, which allows insertion therethrough of threeilluminated pilot tubes each having an outer diameter of 1.65 mm (16ga.) and an inner bore diameter of 0.9 mm (20 gs.). It is a multiportillumination system having three pilot tubes. The tubes are connectednear their ends to plates which are sutured to the pars plana. Very thininstruments, of 20 gauge or less, may be inserted and manipulatedthrough the tubes. A bunch of hair-thin optical fibers are formed,within the pilot tube, into an optical fiber tube whose bore forms theinner diameter of the pilot tube. Each of the tubes transmits lightthrough its bundle of optical fibers and transmits infusion fluids, suchas silicon oil, through its bore.

There are a number of disadvantages to the Storz system. First, andprimarily, it requires three large incisions, each of 2.8 mm in length,and requires the insertion of three relatively large diameter pilottubes through the incisions. The number and size of those cuts may be aserious problem in many surgical procedures. Secondly, some surgeons donot wish to be limited to using instruments which fit through the pilottubes, i.e., instruments of less than 20 gauge.

An article entitled "A New Endoillumination Infusion Cannula For ParsPlana Vitrectomy" by K. Zinn, A. Grinblat, H. Katzin, M. Epstein and C.Kot, Ophthalmic Surgery, Vol. 11, No. 12, Dec. 1980, pgs. 850-854,incorporated by reference herein, describes a combined illumination andinfusion system, which was not manufactured commercially. The infusioncannula (tube for infusion liquids) is within a bundle of opticalfibers.

SUMMARY OF THE INVENTION

In accordance with the present invention a single, relatively thick,optical fiber conducts light from a light source to within the eyeballduring eye surgery. The distal end of the optical fiber, which is withinthe eyeball, is shaped to provide a selected type of illumination. Thatdistal end may be moved further inward toward the rear of the eyeball,or withdrawn, during the operation.

The optical fiber extends through a cannula needle which is integralwith a plate. The cannula is positioned through a cut in the eyeball andthe plate is sewn onto it. The cannula conducts fluid, such as salinesolution (physiological balanced salt solution), gas or silicon oil,into the eyeball.

A connection tube connects the cannula to a juncture device having abore therein. An arm of the juncture device is connected to a tubeleading to a source of infusion fluid. The body of the juncture devicehas a cap member secured thereon. An "O" ring within the cap seals thejuncture device and is positioned around the optical fiber. The capmember may be screwed further down on the body to increase the pressureof the "O" ring on the optical fiber.

The O.D. (Outer Diameter) of the optical fiber is smaller than the I.D.(Inner Diameter) of the bores of the cannula, connecting tube andjuncture device so that the fluid may flow around the optical fiberwithin those bores.

The illumination and infusion system of the present invention may beused in surgical eye operations in which the surgeon needs both hands tomanipulate instruments, for example, in the transplantation of retinalpigment epithelia cell and submacula and subretinal operations.

OBJECTIVES OF THE INVENTION

It is an objective of the present invention to provide a combined fluidinfusion and illumination system for eye surgery in which both hands ofthe surgeon are free to manipulate surgical instruments because thesurgeon, or his assistants, need not hold the device in place during thesurgical operation.

It is a further objective of the present invention to provide such asystem in which the tip free end (distal end) of the optical fiber maybe adjusted, and held in place, to illuminate different internal areasof the eyeball.

It is a further objective of the present invention that at least theportions in contact with the patient's body fluids, namely, the plateand cannula and optical fiber, may be replaced and the remainder of thesystem may be sterilized, or the entire system may be disposable.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objectives and features of the invention will be apparent from thefollowing detailed description, taken in conjunction with theaccompanying drawings.

In the drawings:

FIG. 1 is a side view of the system of the present invention;

FIG. 2 is an enlarged exploded side view of the juncture device of thepresent invention;

FIG. 3A is a side cross-sectional view of the juncture device as shownin FIG. 2;

FIG. 3B is a side cross-sectional view of an alternative juncture deviceusing a round cross-sectional "O" ring;

FIGS. 4A-4D are enlarged views of alternative free distal tip ends ofthe optical fiber;

FIG. 5 is a front view of the plate member; and

FIG. 6 is an enlarged cross-sectional view of the cannula portion.

DETAILED DESCRIPTION

The adjustable miniature panoramic illumination and infusion system forretinal .surgery of the present invention is illustrated in FIG. 1. Itis especially useful in complicated retinal detachment surgery.

In the human eye the wall of the eye consists of three layers ("tunics")which, from outward to inward, are the fibrous, vascular and sensorytunics. The retina is the sensory tunic and has the form of a cupapplied to the inner portion of the choroid. Its sensory layersterminate at the liplike ora serrata. The retina contains lightsensitive receptors (visual cells) and impulse carrying nerve cells(neurons). Due to the placement of the retina it is necessary, duringsurgery, that the illumination cover a wide field, be directed withinthe eyeball and be directed at the back of the eyeball.

As shown in FIG. 1, a fluid connector 10 is a male connector adapted tomate with a conventional fluid female connector (not shown) for fluidinfusion during eye surgery. The tube 11 leads from fluid source 12 tothe female connector. A suitable fluid may be a conventional salinesolution, silicon oil or perfluorocarbon liquid or perfluorocarbongases, see Lincoff, H., et al, "The perfluorocarbon gases in thetreatment of retinal detachment", Ophthalmology, 90:546-551 (1981);Chang, "Low-Viscosity Fluorochemicals in Vitreous Surgery", Am. Jnl.Ophthalmol., 103:38-43 (1987); Chang et al, "Controlled Delivery ofPerfluorocarbon Liquids", Am. Jnl. Ophthalmol., 107:299-300, 1989; thethree articles being incorporated by reference.

The male fluid connector 10 has a bore and is attached to fluidconduction tube (cannula) 13, which is preferably 22 cm. in length. Theend 14 of tube 13 is connected, by a metal band, to the arm 15 of thejunction device 16, shown in enlarged drawing FIG. 2. The body portion17 of junction device 16 has a bore 18 through which a single opticalfiber 19 extends.

Preferably the optical fiber 19 is a plastic optical fiber havingpreferably an outer diameter of 0.5 mm. (small model) or alternativelyan O.D. of 0.73-0.75 mm (larger model).

An optical fiber generally consists of a solid core, which may betransparent glass or plastic of a higher refractive index, and a verythin cladding surrounding the core, the cladding being a transparentmaterial of a lower refractive index The optical fiber is covered with aprotective sheath which surrounds the outer cladding. In the case ofplastic optical fiber, the protective sheath may be relatively thickcompared to the optical fiber. Preferably the plastic optical fiber isfree to slide within its protective sheath.

Plastic optical fibers, due to their flexibility and relatively lowcost, are preferable. Generally plastic optical fibers are formed of atransparent synthetic resin-based material, for example, polystyrene andresins, such as polymethylmethacrylate. Examples of such resins aregiven in U.S. Pat. No. 4,778,245, incorporated by reference. Generallythe core is polystyrene based and has an acrylic based cladding, or thecore is acrylic based and has a cladding of fluorinated PMMA-acrylic.

The single thick optical fiber 19 (light pipe), consisting of a core andits cladding, is covered by a black plastic tubular sheath 20 having anouter diameter (O.D.), for example, of 2.0 mm, which leads from junctiondevice 16 to a conventional light male connector 21. The connector 21fits into a female light connector of a standard high intensity lightsource 36, such as a zenon or halogen bulb in an enclosure. Theconnector 21 is a one-piece aluminum member.

The junction device 16 has a front tubular nose portion 25 which fitsinside the inner end of flexible tube (cannula) 26. The tube 26 ispreferably 20 mm O.D. and 12 cm. long. The outer end 27 of the tube 26fits tightly on a plate member 28 having a hole therethrough, the holeleading to an integral extending tubular cannula (needle) portion 29.The plate member 28 is adapted to be removably sewn to the eyeball(fibrous tunic) at the start of the operation. Preferably the cannulaportion 23 is 0.9 mm. O.D., 4.0 mm. in length, or in the range 3.5-6.0mm, and has a bore of 0.75 mm I.D. (Inner Diameter) and 0.9 mm O.D. foran optical fiber of 0.5 mm O.D. (small model) and a bore of 0.95 I.D.and 1.1 mm O.D. for the larger model having an optical fiber of0.73-0.74 O.D. The optical fiber 19 fits through and extends beyond thefree end point 30 of the cannula portion 29. There is sufficient roombetween the outer diameter of the fiber optic and the inner diameter ofthe tube 26 and the outer diameter of the fiber optic and the innerdiameter of the cannula portion 29 for the free flow of the infusionfluid.

As shown in FIG. 2, the bore 31 of the arm portion 15 leads to the bore18 of the body portion 17 and conducts infusion fluid thereto. The rearend of the body portion 17 has external screw threads 32 which mate withthe internal screw threads of nut cap member 34. An "O" ring 40 of asuitable resilient silicon plastic is a ring having a flat, or round,outer surface and an I.D. which is the same 0.5 or 0.73-0.75 as the O.D.of the optical fiber. The ring 40 fits over the optical fiber 19 and iswithin the cap member 34.

When the cap member 34 is tightened down onto the body portion 17, the"O" ring 40 is squeezed about the optical fiber 19 and forms afluid-tight seal. When so tightened, the optical fiber 19 cannot bemoved forward or backwards.

However, the free end 35 of the optical fiber 19 may be adjusted forwardor backwards, relative to the end 30 of the cannula portion 29, byloosening cap member 34 and pushing, or pulling, the optical fiber 19.This adjustment permits the surgeon to exactly locate, and re-locate,the optical fiber end 35 within the eyeball during the operation.

As shown in FIG. 2, the junction device 16 has a body portion 17 havingan O.D. of 50 mm and is 2.5 cm. long. Its arm portion 15 is 70 mm longand has an O.D. of 20 mm. The bore 18 is 0.6 or 0.78 mm I.D. The capmember is 9.0 mm. long and has a knurled surface and an O.D. of 3.0 mm.The orifice 42 in the end of the cap member, through which the opticalfiber extends, is 0.7 mm for the small model and 0.95 mm for the largermodel. The external thread extends for 8.0 mm. and the bore 43 is 0.78mm I.D., the bore 43 being an extension of the bore 18.

As shown in FIG. 5, a front view of the plate member 28, it is 3.0 mmwide (at its center). All of the metal portions of the device arepreferably made of surgical grade stainless steel.

It will be understood that the dimensions set forth above constitute apreferred example of the present invention and that modifications may bemade therein.

As shown in FIG. 4A, the distal end (tip or free end) of the opticalfiber may be formed as a rounded cone 35A. In FIG. 4B it is formed witha flat end 35B having bevels, to provide a wide angle of illumination.In FIG. 4C it is formed with a rounded end 35C to provide a wide angleof illumination with a smaller reflection level, compared to the shapeof FIG. 4B. In FIG. 4D it is formed with a flat and angled face having apolished tip 35D. A miniature mirror 50, preferably a front surfacesilver coating, may be positioned to reflect the light at a selectedangle.

As shown in FIG. 6 the cannula portion 29 has a bore 45 whose I.D. is0.95 mm for a 0.75 mm optical fiber or 0.75 mm for a 0.5 mm opticalfiber. It has an extending cover (lip) 46 which shields the light fromthe optical fiber. The distal tip of the optical fiber may be positionedso that it extends beyond the orifice 47 and is back of the cannulaportion tip 48.

What is claimed is:
 1. A miniature illuminating and infusion system foreye surgery, comprising:(a) a fluid conduction tube adapted to beconnected to a source of infusion fluid; (b) a single optical fiberhaving an outer diameter and a proximal end and adapted to be connectedto a source of light at the proximal end and having a free oppositedistal end, said distal end adapted to provide illumination within aneyeball during an eye operation; (c) a juncture device having a boretherethrough with an inner diameter, wherein the juncture deviceincludes an "O" ring having a bore therein with the optical fiberextending through the bore of the "O" ring to prevent leakage of theinfusion fluid, the fluid conduction tube being connected to thejuncture device to conduct infusion fluid to the junction device bore;(d) a plate adapted to be removably attached to the eyeball duringsurgery and a needle cannula fixed to the plate, the needle cannulahaving a bore with an inner diameter and having a free distal end; (e) aconnecting tube having a bore and connected to the needle cannula andthe juncture device; (f) the optical fiber being within the bores of thejuncture device, the connecting tube and the needle cannula and thedistal end of the optical fiber adapted to illuminate beyond the freedistal end of the needle cannula, the outer diameter of the opticalfiber being smaller than the inner diameter of the juncture device bore,connecting the tube bore and needle cannula bore thereby permittinginfusing fluid to flow around the optical fiber within the bores.
 2. Aminiature illuminating and infusion system for eye surgery,comprising:(a) a fluid conduction tube adapted to be connected to asource of infusion fluid; (b) a single optical fiber having an outerdiameter and a proximal end and adapted to be connected to a source oflight at the proximal end and having a free opposite distal end, saiddistal end adapted to provide illumination within an eyeball during aneye operation; (c) a juncture device having a bore therethrough with aninner diameter, wherein the juncture device includes a cap member, an"O" ring within the cap member and around the optical fiber and manualadjustment means to tighten and loosen the pressure of the "O" ring onthe optical fiber by moving the cap member, the fluid conduction tubebeing connected to the juncture device to conduct infusion fluid to thejuncture device bore; (d) a plate adapted to be removably attached tothe eyeball during surgery and a needle cannula fixed to the plate, theneedle cannula having a bore with an inner diameter and having a freedistal end; (e) a connecting tube having a bore and connected to theneedle cannula and the juncture device; (f) the optical fiber beingwithin the bores of the juncture device, the connecting tube and theneedle cannula and the distal end of the optical fiber adapted toilluminate beyond the free distal end of the needle cannula, the outerdiameter of the optical fiber being smaller than the inner diameter ofthe juncture device bore, connecting the tube bore and needle cannulabore thereby permitting infusing fluid to flow around the optical fiberwithin the bores.
 3. A system as in claim 2 wherein the juncture devicehas a cylindrical body portion and the adjustment means comprises matingscrew threads on the body portion and the cap member.
 4. A miniatureilluminating and infusion system for eye surgery, comprising:(a) a fluidconduction tube adapted to be connected to a source of infusion fluid;(b) a single optical fiber having an outer diameter and a proximal endand adapted to be connected to a source of light at the proximal end andhaving a free opposite distal end, said distal end adapted to provideillumination within an eyeball during an eye operation; (c) a juncturedevice having a bore therethrough with an inner diameter, the fluidconduction tube being connected to the juncture device to conductinfusion fluid to the junction device bore; wherein the juncture deviceincludes a body portion, a cap member, an "O" ring within the cap memberand around the optical fiber and manual adjustment means to tighten andloosen the pressure of the "O" ring on the optical fiber by moving thecap member; (d) a metal plate adapted to be removably attached to theeyeball during surgery and a metal needle cannula integral with theplate, the needle cannula having a bore with an inner diameter and afree distal end; (e) a connecting tube having a bore and connected tothe needle cannula and the juncture device; (f) the optical fiber beingwithin the bores of the juncture device, the connecting tube and theneedle cannula and the distal end of the optical fiber adapted toilluminate beyond the distal free end of the needle, the outer diameterof the optical fiber being smaller than the inner diameter of thejuncture device bore, connecting the bore and needle cannula borethereby permitting infusing fluid to flow around the optical fiberwithin the bores.
 5. A system as in claim 4 wherein the body portion iscylindrical and the adjustment means comprises mating screw threads onthe body portion and the cap member.
 6. A system as in claim 5 whereinthe distal end of the optical fiber is adjustable, during the surgery,relative to the distal end of the needle by loosening the cap member onthe body portion.